Distribution of age, sex, race, and ethnicity in COVID-19 clinical drug trials in the United States: A review.
Contemp Clin Trials
; 123: 106997, 2022 Dec.
Article
in English
| MEDLINE | ID: covidwho-2104484
ABSTRACT
BACKGROUND:
COVID-19 quickly overwhelmed the world, but disproportionately affects certain communities, particularly minority groups. Despite overrepresentation among COVID-19 cases and death, minority groups were underrepresented in some of the early COVID-19 clinical trials.OBJECTIVE:
To assess and compare the demographic characteristics of COVID-19 clinical trial participants to national COVID-19 data.METHODS:
PubMed was searched from December 1, 2019 to November 24, 2020, for randomized controlled trials evaluating a pharmacologic treatment for COVID-19 patients from one or more U.S. sites written in the English language following the PRISMA checklist. Descriptive statistics were calculated to characterize patient demographics enrolled in the included clinical trials, as well as for comparison with national COVID-19 data.RESULTS:
A total of 4472 records were identified, of which 16 studies were included. The median number of participants was higher in studies of nonhospitalized patients compared to those of hospitalized patients (n = 452 [range 20-1062] vs n = 243 [152-2795]). Ten (63%) studies reported mean or median ages of 50 years or older among all study arms. Males comprised more than half of the study cohort in ten (63%) studies. Race and ethnicity were reported separately in four (25%) studies but were combined when reported in five (31%) studies, while six (38%) reported only race or ethnicity. Proportional representation based on age, sex, race, and ethnicity was evident in some trials, but not in others, when compared to national data.CONCLUSION:
Overall, participants often did not reflect the actual population with COVID-19 and demographic characteristics were inconsistently reported.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
COVID-19 Drug Treatment
Type of study:
Cohort study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
/
Reviews
Limits:
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
North America
Language:
English
Journal:
Contemp Clin Trials
Journal subject:
Medicine
/
Therapeutics
Year:
2022
Document Type:
Article
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